The venture should help Amgen make use of new FDA guidance allowing broader use of real-world evidence to speed approval of oncology drugs to market.
Biotechnology giant Amgen and data integrator Syapse have announced a partnership to create observational research analytics that will “assess treatment areas of unmet need in oncology.” Syapse will search its network to find patients who could be eligible for Amgen-sponsored clinical trials. The idea will be to bring the trials to the patients in community health systems.
The collaboration, announced jointly on Thursday by the 2 companies, will allow physicians and researchers within the Syapse Network to gain access to research opportunities along with real-world insights. Amgen will gain real-world evidence that may be used in filings in oncology with the FDA.
Last year, FDA announced a strategic framework for expanding the use of this type of evidence in drug approvals. A webinar sponsored by the National Pharmaceutical Council specifically discussed the potential for expanded use of observational studies in drug approvals. Under the collaboration, Amgen and Syapse will work together on standards for using real-world evidence to speed therapies to market.
“As cancer remains one of the leading causes of death around the world, emerging software and data analytic tools are creating exciting opportunities to more rapidly develop and deliver targeted treatment options to patients,” said Mike Nohaile, senior vice president of strategy, commercialization, and innovation at Amgen. “Our collaboration with Syapse supports this effort by leveraging real-world evidence to accelerate bringing new oncology treatments to market and empowers healthcare providers with more robust insights and decision-making tools to improve patient care.”
Sypase chief executive officer Ken Tarkoff, who explained the company’s product and mission in a 2017 interview with Evidence-Based Oncology™, said, “Through this collaboration and the strategic relationships we’ve built with community health systems globally, we aim to develop evidence of clinical utility that can be used to bring molecularly targeted treatments to market more quickly and ensure more diverse groups of patients can access them.”